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Study 3 of 3 for search of: | Congo, The Democratic Republic of the |
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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women's and Children's Health Research Bill and Melinda Gates Foundation John E. Fogarty International Center (FIC) National Center for Complementary and Alternative Medicine (NCCAM) National Institute of Dental and Craniofacial Research (NIDCR) National Cancer Institute (NCI) RTI International University of North Carolina Kinshasa School of Public Health, Democratic Republic of Congo |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00538382 |
The objective of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of a standard dose of orally administered artesunate, in order to determine if the current adult dose (200 mg) is appropriate in parasitemic pregnant women when compared to the same women at three months postpartum and to parasitemic non-pregnant women. Preliminary evidence on safety, tolerability and efficacy will be gathered.
Condition | Intervention | Phase |
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Malaria |
Drug: Artesunate |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Phase I Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo |
Estimated Enrollment: | 48 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
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Case: Experimental
Cases are defined as parasitemic pregnant women during the second trimester (22-26 weeks gestation) and the third trimester (32-36 weeks gestation).
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Drug: Artesunate
A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
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Non-pregnant Control: Active Comparator
Non-pregnant controls are defined as parasitemic non-pregnant women recruited from the same community as the cases.
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Drug: Artesunate
A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
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Internal Control: Active Comparator
Internal controls are defined as the same women(cases)at three months postpartum.
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Drug: Artesunate
A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Cases:
Inclusion Criteria for Non-pregnant Controls:
Inclusion Criteria for Internal controls:
Exclusion Criteria for Cases:
Exclusion Criteria for Non-pregnant Controls:
Exclusion Criteria for Internal Controls:
Contact: Linda Wright, M.D. | 301-402-0830 | wrightl@mail.nih.gov |
Contact: Macaya Douoguih, M.D., M.P.H. | 301-496-7685 | douoguihm@mail.nih.gov |
Congo, The Democratic Republic of the | |
Kingasani Maternity Clinic | Recruiting |
Kinshasa, Congo, The Democratic Republic of the | |
Contact: Marie Onyamboko, M.D. +243 99 00 24 201 akatshimarie@yahoo.fr | |
Principal Investigator: Antoinette Tshefu, M.D., M.P.H. |
Principal Investigator: | Carl Bose, M.D. | University of North Carolina |
Principal Investigator: | Antoinette Tshefu, M.D., M.P.H. | Kinshasa School of Public Health |
Study ID Numbers: | GN02- PK/PD of artesunate |
Study First Received: | September 28, 2007 |
Last Updated: | September 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00538382 |
Health Authority: | United States: Food and Drug Administration |
Malaria Pregnancy Artesunate |
Pharmacokinetics Pharmacodynamics Democratic Republic of Congo |
Artesunate Protozoan Infections Parasitic Diseases Malaria |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Amebicides Pharmacologic Actions |